HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

NCT03028688 | Completed DMC

• 1 other identifier: HP-00071111
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a risk for low oxygen saturation during the procedure, which presents a significant patient safety issue. The purpose of the clinical trial is compare the current anesthesia standard of care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.

Conditions

Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• Hypoxemia event (Low blood oxygen level)

  The primary outcome measure will be occurrence of a low blood oxygen level defined by oxygen saturation less than 92% for greater than 15 seconds at any point during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.

  The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.

Secondary Outcomes (2)

• Hypercarbia event (Elevated blood CO2 level)

  The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.

• Hypotension event (Low blood pressure)

  The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.

Study Arms (2)

Current standard of care

NO INTERVENTION

Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed.

High flow nasal cannula group

EXPERIMENTAL

Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed.

Device: High flow nasal cannula oxygen

Interventions

High flow nasal cannula oxygen DEVICE

Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.

High flow nasal cannula group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.
• Age greater than or equal to 18 years

You may not qualify if:

• Propofol, midazolam, or fentanyl allergy
• Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion of the attending anesthesiologist)
• Any procedure with planned electro-cautery as a high-inspired oxygen concentration could increase the risk for airway or esophageal fire.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Anesthesia Patient Safety Foundation: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.

  PMID: 32398433 DERIVED

Study Officials

• Michael A Mazzeffi, MD MPH

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 23, 2017
• Study Start: June 21, 2017
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)